Assessment of the effect of drug formulation on the extent of the pharmacokinetic interaction between St. John's Wort and tacrolimus
- Conditions
- Pharmacokinetic interaction of St. John's Wort and tacrolimusHealthy volunteers
- Registration Number
- DRKS00023556
- Lead Sponsor
- niversität Heidelberg, Medizinische Fakultät
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 20
BMI 18-30 kg/m² and body weight = 40 kg.
Participation in a genotyping study to determine CYP3A5 genotype.
Willing to use specified methods of contraception.
Agreement to follow specified dietary reqirements (e.g. grapefruit is not allowed).
Clinically significant or relevant abnormalities in the medical history, physical examination, and laboratory evaluation as assessed by the investigator.
Any medical disorder that may require treatment or make the participant unlikely to fully complete the trial, or any condition that presents undue risk from the IMP or trial interventions.
Clinically relevant ongoing or clinically relevant history of physical or psychiatric illness as judged by the investigator.
Pregnancy or breast feeding.
Any acute or chronic illness or clinically relevant finding known or expected to modify absorption, distribution, metabolism, or excretion of tacrolimus.
Any known history of severe allergic or anaphylactic reactions to drugs or food or any other clinically significant allergies.
Any known allergies to the trial drugs, to other macrolides, or further ingredients of the administered IMPs.
Known light hypersensitivity of the skin.
Clinically relevant findings in screening investigations.
A positive result in the drug screening test at screening.
Use of any medication (prescription medication, non-prescription medication including multivitamin or herbal preparations) with active ingredients (except hormonal contraception, iodine, and thyroid hormones), within a period of less than 5 times the respective elimination half-time with regard to the expected date of the first dose of IMP.
Any intake of substances known to induce relevant metabolizing enzymes or drug transporters within a period of less than 14 days with regard to the expected date of the first dose of IMP.
Expected noncompliance to refrain from alcohol 24 hours before the pharmacokinetic days, or pathological alcohol consumption.
Use of an IMP within 30 d prior to the expected date of receiving the first dose of IMP or active enrolment in another drug or vaccine clinical trial.
QTcF > 440 ms (males) or > 460 ms (females).
Regular smoking.
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To compare the change in tacrolimus pharmacokinetics during enzyme induction with St. John's Wort after administration of two different drug preparations (Envarsus versus Prograf).
- Secondary Outcome Measures
Name Time Method To evaluate whether CYP3A4 activity (estimated with an oral midazolam microdose) correlates with the pharmacokinetic changes.<br>To evaluate a potential impact of the CYP3A5 rs776746 polymorphism on the extent of the interaction.